Page 2 - Dr. William S. Gartland 
The Guidelines focus attention on the control of aerosol-producing 
procedures (although not exclusively). They do not sufficiently address 
the potentials for accidents-and likely (or unlikely) consequences - 
that may occur in large-scale commercial operations. 
Assessment of Increased Risk 
There is no discussion of the assessment of increased degree of risk 
assumed to be associated with work greater than 10 liters. Where does 
the increased risk come from; what is its nature? Does the degree of risk 
and the nature of hazards change as the size of the experiment or operation 
increases? Until the nature of the hazards are discussed and assessed 
for different magnitudes of production, the associated risks and attendant 
control measures are quite open to question. 
Format and Language 
The format and language of the draft guidelines for physical containment 
of large scale uses are similar to, but not entirely consistent with, the 
NIH Guidelines. As discussed in comment (1), it is obvious that the 
guidelines for large scale uses are derived from laboratory research 
operations, therefore, at the very least, the format and language for Part 
VII should be carefully reviewed and edited to be consistent with that of 
existing Guidelines. A great deal of explicitness in procedures and 
requirements now incorporated in existing Guidelines has not been 
incorporated in the draft guidelines for large scale uses. For example, in 
the draft Part VII, the type of protective clothing, and equipment or 
manipulations that produce aerosole are not specified to the same degree or 
in the same terminology as the existing Guidelines. Until consistency is 
achieved, it does not seem worthwhile to comment further on specific 
provisions . 
Occupational Health and Safety 
Personnel and environmental surveillance and routine monitoring, as well 
as occupational safety and health considerations are essentially absent 
from the draft for Part VII. Routine monitoring provides essential 
information on the efficiency of control technology and, with rigorous 
record keeping, can contribute invaluable data toward risk assessment 
and control. The following factors are pre-requisite elements of such a 
program. 
a. Registry of potentially exposed individuals 
b. Work area monitoring program, including air and surfaces, for 
viable recombinant DNA host-vector organisms. 
[ 262 ] 
